Aspirin 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aspirin

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N02BA01

INN (International Name):

Aspirin

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100

Patient Information leaflet

ASPIRIN 300MG TABLETS
PATIENT INFORMATION LEAFLET
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor or pharmacist if your symptoms worsen or do
not improve.
_ _
IN THIS LEAFLET:
1.
WHAT THIS MEDICINE IS FOR
2.
BEFORE YOU TAKE THE MEDICINE
3.
HOW TO TAKE THE MEDICINE
4.
POSSIBLE SIDE EFFECTS
5.
STORING THE MEDICINE
6.
FURTHER INFORMATION
1.
WHAT THIS MEDICINE IS FOR
Aspirin 300mg Tablets contain aspirin, which belongs to a group of
medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how
the body responds to
pain, swelling and high temperature.
This medicine is used to relieve:
•
sprains, strains, rheumatic pain, muscular aches and pains, sciatica
(pain in the back of the thigh)
and lumbago (lower back pain)
•
fibrositis (joint pain), joint swelling and stiffness
•
neuralgia (nerve pain)
•
headache and migraine
•
dental pain, period pain
•
sore throat and fever (high temperature)
•
the symptoms of colds and flu.
2.
BEFORE YOU TAKE THE MEDICINE
DO NOT TAKE ASPIRIN 300MG TABLETS IF YOU:
•
are under 16 years old, unless your doctor tells you to
•
have or have ever had a stomach ulcer, perforation or bleeding
•
are allergic to aspirin, to any of the ingredients (listed in section
6), or to ibuprofen or other
painkillers (an allergic reaction may be recognised as shortness of
breath, runny nose, skin rash
or itching)
•
have severe kidney or liver disease
•
suffer from a bleeding disorder (e.g. haemophilia), or are taking
medicines to thin your blood,
asthma or gout
•
are taking other NSAID painkillers (e.g. ibuprofen, naproxen)
•
are taking medicines for thinning the blood (anticoagulants)
•
are in the last 3 months of pregnancy or are breastfeeding
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING ASPIRIN 300MG TABLETS
IF YOU:
•
have asthma or have suffered from asthma
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet containsAspirin 300mg.
For excipients see Section 6.1
3
PHARMACEUTICAL FORM
Tablet
White circular with break line on one face
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Anti-inflammatory indications:
Symptomatic relief of sprains, strains, rheumatic pain, sciatica,
lumbago, muscular
aches, fibrositis, joint swelling and stiffness.
Analgesic and antipyretic indications:
Mild to moderate pain including headache, migraine, neuralgia,
toothache, sore
throat, period pains, aches and pains, symptomatic relief of influenza
and feverish
colds.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Adults & children over 16 years: 1 - 3 tablets every four hours, or as
directed by a
doctor.
Not more than 4 doses in 24 hours.
Do not give to children aged under 16 years, unless Aspirin has been
specifically
prescribed for that child (e.g. for Kawasaki’s disease).
Elderly: A lower dose is recommended.
The tablets to be taken orally with water.
4.3
CONTRAINDICATIONS
Aspirin is contraindicated in patients with;
•
active peptic ulceration or a history of peptic ulceration.
•
Haemophilia, haemorrhagic disease or a history of bleeding disorders.
•
Gout or a history of gout.
•
Hypersensitivity to aspirin (e.g. asthma, rhinitis, angioedema or
urticaria), other NSAIDs or other tablet excipients
•
During the third trimester of pregnancy
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is a possible association between aspirin and Reye’s syndrome
when
given to children. Reye’s syndrome is a very rare disease, which
affects the
brain and liver and can be fatal. For this reason aspirin should not
be given to
children under 16 years unless specifically indicated (e.g. for
Kawasaki’s
disease).
Patients with rare hereditary problems of galactose intolerance, the
Lapp
lactose deficiency or glucose- galactose malabsorption should not take
aspirin.
Patients should be warned:
•